Wednesday, December 4, 2002

Suman Sahai

To ensure that Indian farmers get the best possible seeds, any variety approved for their use must be thoroughly tested by the best institutions under the best possible conditions. This does not seem to be the case with Proagro’s controversial GM mustard variety.The safety of Proagro’s mustard is in question. Safety tests for the GM mustard as human food and as animal feed were conducted by Proagro itself, by feeding seeds and leaves of the transgenic plant to pigeons and rabbits. The company reportedly supplied both the samples to be tested and the controls against which the samples had to be tested, making the tests a farce. Moreover, the tests were not conducted in any government laboratories which are open to scrutiny but in private institutions (FIPPATin Chennai and Sriram Institute, Delhi). Even in these privately conducted tests, there was no involvement of scientists from the national agricultural system. The safety data were accepted by the GEAC despite this unusual practice.

Equally questionable is the manner in which the field trials were done for Proagro’s GM mustard.The Aventis/Proagro hybrids have not gone through the prescribed procedure ofthe All India Coordinated Croptrials as crop varieties in India are required to do. In India, all varieties have to undergo rigorous testing in all zones at 40-50 locations and a variety is only notified after this process is completed, a process which lasts over three years. The Aventis/ Proagro mustard has been tested by ICAR ( Indian Council of Agricultural Research ) for only one season, in just 4 locations , in a total of 3 zones!

Curiously enough , like in the food and feed safety tests, it is Proagro itself which has supplied the bulk of the data on field performance to the GEAC, on the basis of tests it has done itself on its own trial variety. The clear cut conflict of interest – the industry providing the data on which its performance will be judged, does not seem to disturb the GEAC. In a deplorable departure from ethical practice, the GEAC does not seem unduly worried either , about the potential for Proagro to manipulate the data both on its field performance and on human and animal safety tests. It has trustingly accepted what Proagro has supplied.

So glaring has been the pro-industry bias of the GEAC , that the Director General of the ICAR has been constrained to criticise it. The ICAR chief has said that the GM mustard data are not sufficient to justify commercial release and that additional tests would have to be done , specially since most of the data provided to the GEAC have been generated by the company itself. The DG of the ICAR also said that “no exceptions can be made in the case of Proagro”, implying that this had indeed been the case.

This is significant in view of the GEAC’s obduracy in insisting that Proagro would not be required to conduct any additional tests. When the decision on release of the mustard variety was deferred from the meeting of 7 November, 2002,to one scheduled for 10 December, the GEAC had categorically stated that the Committee would only review the old data and not ask Proagro for any new data.

One is forced to question this unseemly rush in giving clearance to Aventis’ mustard despite several outstanding and unresolved questions. More so since some Indian labs are on the threshold of releasing high performance non- GM hybrid mustard varieties.Promising hybrid mustard varieties are being developed in the Indian Agricultural research Institute/ Delhi, in PunjabAgriculturalUniversity/ Ludhiana and in HaryanaAgriculturalUniversity/ Hissar. All three labs are very close , about two to three years , from releasing non GM mustard varieties with far better performance than the Aventis variety being pushed by the government.

This great desire to see the Proagro mustard variety through at all costs,has alarmed some NGOs sufficiently to petition the Chief Vigilance Commissioner to investigate the conduct of India’s scientific and regulatory agencies, particularly the GEAC. The known proclivity of the multinational sector to buy influence in governments and decision-making bodies and the complete lack of transparency in the functioning of the GEAC has fuelled suspicions of corruption and irregularities.

It continues to remain a matter of concern that the GEAC resolutely refuses to respond to requests from the NGO community seeking information on the results of field trials of both Bt cotton and GM mustard . Despite repeated requests and several letters requesting information about the results of field trials of transgenic varieties, Sri. A.M. Gokhale, Chairman GEAC, has not responded to the queries made. This evasive conduct would seem to suggest that the GEAC is hiding unpleasant truths that cannot withstand public scrutiny. In addition to the results of test data, Gene Campaign has also been demanding that in the interests of transparency and credibility, independent experts must be allowed to visit test sites and evaluate the performance of GM crops.

If India is to develop as a leading agricultural country capable of absorbing and implementing new technologies, then the scientific and regulatory agencies will have to demonstrate far greater maturity and sensitivity to public concerns than they have been doing so far. This ‘Insider club shrouded in secrecy , taking decisions on who knows what basis’,is not acceptable. Information onProagro’s mustard and every other GM variety considered for release will have to satisfy all possible health, environmental and ecological criteria, to the satisfaction of the public.

Monday, December 2, 2002

If proof were needed that India was not ready to absorb and implement a complex technology like GM technology, one only has to watch the performance of the agencies set up to regulate this sensitive technology, theGEAC ( Genetic Engineering Approval Committee ) in particular. The GEAC had convened a meeting on 7 November, 2002 to grant approval to Proagro’s GM mustard varieties. NGOs and farmers organisations raised a storm of protest before and during the meeting, opposing the release of the GM mustard. The committee decided to defer the decision, ostensibly to ‘review’ the data . It is believed that the decision was delayed so as to ride out the protests and clear the variety when things were quiet again. Amidst a barrage of allegations that the GM mustard had not cleared safety tests and not been sufficiently tested in the fields, NGOs like Gene Campaign had been demanding the release of the field data presented by Proagro, andthat the company should be required to do new field testsmonitored by independent experts . The GEAC has been adamant that no data would be released and no further field trials would be done. Now suddenly, with nothing having changed,it has decided to hold a meeting on 10 December to take a decision on the GM mustard variety.

In the meantime, the conduct and bias of the GEAC has come in for criticism from an unlikely source . Dr. Panjab Singh, Director General of ICAR ( Indian Council of Agricultural Research ) has saidthat the mustard data are not sufficient to justify commercial release and that additional tests would have to be done , specially since most of the data provided to the GEAC have been generated by the company itself. Dr. Singh added “no exceptions can be made in the case of Proagro”, implying that this had been the case. The clear cut conflict of interest – the industry providing the data on which its performance will be judged, does not seem to disturb the GEAC, so intent are they on granting approval to Proagro.

The GEAC is the regulatory body that is charged with the responsibility of assessing the results of field trials of GM crops and decide whether or not the results are clean and convincing enough to warrant approval for commercial release. This should not be a difficult task . There are supposed to be reference standards for testing GM crops,the field trial results have to be evaluated against these standards and a considered decision taken if the results are convincing . If not, more tests should be done . If even then the results are not clear , the Precautionary Principle should be invoked and the commercial release of the crop should be deferred or denied.

All this naturally needs to be done in an open and transparent mannerand with accountability to the public. The laws of countries like the US, Canada, Australia and the EU have statutory provisions for public participation in decision-making, public discussions on risk and benefits of GM crops, the nature and location of field trials, the results of such trialsand other aspects ofthe testing of GM crops. Most information (except some kinds ofconfidential Business Information ) is in the public domain and access to that information cannot be denied to the public. Here in India however, the GEAC is a law unto itself. It functions like an insider club , cloaked in secrecy and about as transparent as a concrete wall. The GEAC refuses to respond to enquiries from the public. It even refuses to acknowledge phone calls, e mails and registered letters from civil society asking for appointments to discuss public concerns or requests for information about field trials of GM crops ( Bt cotton or GM mustard ) . The question that many are asking is that the if the GEAC has nothing to hide, why is it so secretive, why is it hiding behind its concrete wall ? And should such a secretive, non- transparent (and many would say, incompetent) body be allowed to take decisions of such importance?

Hiding facts about the GM field trials is a violation of India’s Right to Information Act under which, barring sensitive areas like defence, the public has a right to know the basis of government conduct and its decisions. In an area which could so directly impact on the health of humans and their livestock, on the agro-biodiversity and the environment of this region, on the livelihoods of farmers and on the sustainability of agriculture for future generations, withholding information and denying the public the right to participate in taking decisions amounts to a criminal offence. If for nothing else, the GEAC should be called up to explain its conduct on this alone.

But this is not all. The way the scientific administration and the regulatory agencies responsible for evaluating the GM crops on offer from the MNCs (there are no crops yet from public research institutions) are conducting themselves, should be the subject of investigations by the Central Vigilance Commission. In fact, fearing corruption and irregularities, civil society organisations have petitioned the Chief Vigilance Commissioner to institute an enquiry into the behaviour of the regulatory agencies concerned with GM crops.

It is commonly known that when government officials go to monitor the field trials and tests of the GM crop ( in this case , Monsanto’s Bt cotton and Proagro’s GM mustard ) , the entire bill for travel, boarding and lodgingand hospitality is paid by the industry whose crop is being evaluated. This is not all. The officials are also paid an honorarium ! Talking about irregularities, to assess whether the GM crop parts like seeds, leaves , oil, oil cake etc are safe for humans and animals, studies have to be conducted to see whether they are toxic or not. The cost ofthese studies on the safety of GM crop products and crop parts for food and animal feedis borne by the concerned industry. This must be the only instance in the world where the industry in question itself controls the data on which the sanction of its product depends.

The conflict of interest within the government agencies running the GM show does not end here. Within the GEAC, all the members are those who are researching GM crops and hope tohave their own GM crops coming up for approval before the same committee. A very ‘I scratch your back- you scratch –mine “ situation. A senior scientist of the ICAR is a member of the GEAC when ICAR itself is an applicant to the GEAC seeking approval for its transgenic crops . What objectivity should one expect in such a situation ? In addition to this, there are no scientists from different fields like social sciences, economics, etc. who would be needed to bring in other perspectives.

The GEAC has no soil scientists or ecologists or entomologists ( to understand insect resistance, as in the case of Bt cotton for example.) , nor experts in any of the environmental sciences. The body is incapable of taking a competent or comprehensive view on the safety and efficiency of the GM crop on the basis of the data provided. Before India’s regulatory agencies precipitate an environmental or human health disaster with their incompetence and their great enchantment of multinational companies, they should be disbanded. India should put on hold the release of GM crops until its regulatory procedure is demonstrably more competent and transparent.

If proof were needed that India was not ready to absorb and implement a complex technology like GM technology, one only has to watch the performance of the agencies set up to regulate this sensitive technology, theGEAC ( Genetic Engineering Approval Committee ) in particular. The GEAC had convened a meeting on 7 November, 2002 to grant approval to Proagro’s GM mustard varieties. NGOs and farmers organisations raised a storm of protest before and during the meeting, opposing the release of the GM mustard. The committee decided to defer the decision, ostensibly to ‘review’ the data . It is believed that the decision was delayed so as to ride out the protests and clear the variety when things were quiet again. Amidst a barrage of allegations that the GM mustard had not cleared safety tests and not been sufficiently tested in the fields, NGOs like Gene Campaign had been demanding the release of the field data presented by Proagro, andthat the company should be required to do new field testsmonitored by independent experts . The GEAC has been adamant that no data would be released and no further field trials would be done. Now suddenly, with nothing having changed,it has decided to hold a meeting on 10 December to take a decision on the GM mustard variety.

In the meantime, the conduct and bias of the GEAC has come in for criticism from an unlikely source . Dr. Panjab Singh, Director General of ICAR ( Indian Council of Agricultural Research ) has saidthat the mustard data are not sufficient to justify commercial release and that additional tests would have to be done , specially since most of the data provided to the GEAC have been generated by the company itself. Dr. Singh added “no exceptions can be made in the case of Proagro”, implying that this had been the case. The clear cut conflict of interest – the industry providing the data on which its performance will be judged, does not seem to disturb the GEAC, so intent are they on granting approval to Proagro.

The GEAC is the regulatory body that is charged with the responsibility of assessing the results of field trials of GM crops and decide whether or not the results are clean and convincing enough to warrant approval for commercial release. This should not be a difficult task . There are supposed to be reference standards for testing GM crops,the field trial results have to be evaluated against these standards and a considered decision taken if the results are convincing . If not, more tests should be done . If even then the results are not clear , the Precautionary Principle should be invoked and the commercial release of the crop should be deferred or denied.

All this naturally needs to be done in an open and transparent mannerand with accountability to the public. The laws of countries like the US, Canada, Australia and the EU have statutory provisions for public participation in decision-making, public discussions on risk and benefits of GM crops, the nature and location of field trials, the results of such trialsand other aspects ofthe testing of GM crops. Most information (except some kinds ofconfidential Business Information ) is in the public domain and access to that information cannot be denied to the public. Here in India however, the GEAC is a law unto itself. It functions like an insider club , cloaked in secrecy and about as transparent as a concrete wall. The GEAC refuses to respond to enquiries from the public. It even refuses to acknowledge phone calls, e mails and registered letters from civil society asking for appointments to discuss public concerns or requests for information about field trials of GM crops ( Bt cotton or GM mustard ) . The question that many are asking is that the if the GEAC has nothing to hide, why is it so secretive, why is it hiding behind its concrete wall ? And should such a secretive, non- transparent (and many would say, incompetent) body be allowed to take decisions of such importance?

Hiding facts about the GM field trials is a violation of India’s Right to Information Act under which, barring sensitive areas like defence, the public has a right to know the basis of government conduct and its decisions. In an area which could so directly impact on the health of humans and their livestock, on the agro-biodiversity and the environment of this region, on the livelihoods of farmers and on the sustainability of agriculture for future generations, withholding information and denying the public the right to participate in taking decisions amounts to a criminal offence. If for nothing else, the GEAC should be called up to explain its conduct on this alone.

But this is not all. The way the scientific administration and the regulatory agencies responsible for evaluating the GM crops on offer from the MNCs (there are no crops yet from public research institutions) are conducting themselves, should be the subject of investigations by the Central Vigilance Commission. In fact, fearing corruption and irregularities, civil society organisations have petitioned the Chief Vigilance Commissioner to institute an enquiry into the behaviour of the regulatory agencies concerned with GM crops.

It is commonly known that when government officials go to monitor the field trials and tests of the GM crop ( in this case , Monsanto’s Bt cotton and Proagro’s GM mustard ) , the entire bill for travel, boarding and lodgingand hospitality is paid by the industry whose crop is being evaluated. This is not all. The officials are also paid an honorarium ! Talking about irregularities, to assess whether the GM crop parts like seeds, leaves , oil, oil cake etc are safe for humans and animals, studies have to be conducted to see whether they are toxic or not. The cost ofthese studies on the safety of GM crop products and crop parts for food and animal feedis borne by the concerned industry. This must be the only instance in the world where the industry in question itself controls the data on which the sanction of its product depends.

The conflict of interest within the government agencies running the GM show does not end here. Within the GEAC, all the members are those who are researching GM crops and hope tohave their own GM crops coming up for approval before the same committee. A very ‘I scratch your back- you scratch –mine “ situation. A senior scientist of the ICAR is a member of the GEAC when ICAR itself is an applicant to the GEAC seeking approval for its transgenic crops . What objectivity should one expect in such a situation ? In addition to this, there are no scientists from different fields like social sciences, economics, etc. who would be needed to bring in other perspectives.

The GEAC has no soil scientists or ecologists or entomologists ( to understand insect resistance, as in the case of Bt cotton for example.) , nor experts in any of the environmental sciences. The body is incapable of taking a competent or comprehensive view on the safety and efficiency of the GM crop on the basis of the data provided. Before India’s regulatory agencies precipitate an environmental or human health disaster with their incompetence and their great enchantment of multinational companies, they should be disbanded. India should put on hold the release of GM crops until its regulatory procedure is demonstrably more competent and transparent.

Wednesday, September 18, 2002

Viewing the impending release of Aventis/ Proagro’s GM mustard variety by the Genetic Engineering Approval Committee (GEAC) with great concern, Gene Campaign today demanded that all data pertaining to the field trials of the this GM mustard be made available to the public. There are very serious charges of irregularities being discussed in the scientific community about the bogus nature of the trials conducted by Aventis/Proagro, the high levels of genetic contamination of non-GM mustard varieties and a less than above board approach to securing a favourable verdict for the release of transgenic mustard. These charges must be either admitted or refuted by the company.

Aventis/Proagro’s transgenic mustard is completely unsuited and irrelevant to India because it contains thebarnase-bar-barstar genes. Barnase -barstar -bar genes are used in Canada to work specifically with herbicide tolerance. That situation does not obtain in India, so what is the point of using these genes here ?

Bar is a herbicide tolerant gene, barnase is an RNAse gene and can destroy any cell unless controlled. It isknown for ‘leaky expression’, which can create unwanted changes, morphological malfunctions and even reduced yields.

1.Most importantly, the efficacy and performance of the Aventis hybrids under trial has been called into question. These varieties do not perform as well as existing Indian varieties , thus giving the farmer absolutely no advantage . All the advantages go to Aventis which seeks to secure a foothold in the Indian seed market, aided by a compliant and compromised scientific bureaucracy.

Gene Campaign demands :

Make the data available on the performance of the Aventis mustard compared to the best Indian mustard varieties.

2. Food and Feed Safety studies for this GM mustard were done by feeding transgenic seeds and leaves to pigeon and rabbits. The reportedly company supplied both the Samples & Controls- for the tests,making the tests a farce.

Safety tests were conducted in private institutions (FIPPAT- Chennai and Sriram Institute, Delhi) without theparticipation of government scientists. Food and Feed Safety data were cleared without proper testing in Government Institutions/ labs.

Demand :

Let the testing protocol for Food and Feed Safety testsbe made public

Identify the source of samples and controls and the testing locations

Make public the safety data on the basis of which the transgenic mustard is getting clearance.

3. Pollen flow & contamination of non-GM mustard

In ICAR conducted tests last year in Pant Nagar, Ludhiana, Kanpur, Mathura and Jabalpur., pollen flow was detected ( in Pantnagar ) up to 75 m. In other locations, officials of the company are rumoured to have influenced the data and shown it to be less on the records than it was.

Even with evidence of pollen flow of 75m. Isolation distance in the Aventis transgenic trials, are recommended as 50m, ensuring genetic contamination of non GM mustard in neighbouring fields.

Demand – Let pollen flow studies be done by public research scientists monitored by an independent panel.

Test all the non-GM mustard in the vicinity of transgenic trials and make the data public. Assess whether or not/how much contamination has taken place.

4. What is the rush in giving clearance to Aventis’ mustard when Indian labs are on the threshold of releasing high performance non- GM hybrid mustard varieties.

Promising hybrid mustard varieties are being developed by Dr. R K KatiarinIARI, Dr. Banga in PAU, Ludhiana and Dr.Dhiraj Kumarin HAU. All three labs are very close ( 2-3 years ) from releasing non GM mustard varieties with better performance than the Aventis variety being pushed by the government.

Demand : Let there be an investigation into which people or agencies are behind this relentless support for Aventis’ transgenic mustard , at the cost of superior non- GM Indian varieties.

5. Who has borne the cost of the members of the MEC ( Monitoring and Evaluation Committee ) and the government nominees of the GEAC who are supposed to monitor and evaluate the field trials ?Has the government or other designated agency borne the cost of those sent to monitor and evaluate the performance ofAventis’ transgenic mustard ?

It is rumored that the companies themselves (Aventis for this mustard and Monsanto for

Bt cotton ) have paid for the travel and hospitality of the government nominees of the regulatory committees. Not only is this highly irregular and morally questionable, what is even worse, it is said that members have received substantial honorariums from the companies for doing the evaluation of their field trials.

Demand : Let the GEAC and MEC members give undertakings that the companies did not underwrite any costs for government members and that no honorariums were paid by the company to the government nominees .This is necessary to establish the credibility of the MEC and GEAC.

6. According to the procedure and protocol of testing GM varieties, each agency (government laboratory or private company ) is required to disclose the details of the varieties used in breeding the GM variety. This is called the passport data .

Demand : Let Aventis/ Proagro reveal the passport data of their transgenic mustard under trial and imminent release. Let Aventis/ Proagro and the NBPGR give an undertaking that all varieties used have been deposited with the NBPGR as required.

7. The GM hybrids has not gone through the prescribed procedure ofthe All India Coordinated Croptrials as crop varieties in India are required to do. In India, all varieties have to undergo rigorous testing in all zones at 40-50 locations and a variety is only notified after this process is completed, a process which lasts over three years. The Aventis/ Proagro mustard has been tested for only one season, in just 4 locations , in a total of 3 zones- and it is ready for release !

8. There is talk that several lines of Indian mustard have been sent to the ProAgro headquarters in Belgium. This is in violation of the law. No genetic material can leave the country without proper procedures and in accordance with the Convention on Biological Diversity . This includes Prior Informed Consent, Material Transfer Agreements and Information Transfer Agreements.

Demand : Let Aventis/Proagro give an undertakingthat this is not the case. That Indian mustard germplasm has not been sent by them to the company headquarters in Belgium.

9. There is some talk to be heard in certain quarters about how Aventis/Proagro are ‘buying influence’ in government departments to get a favourabledecisionfor the release of Bt mustard. This kind of talk undermines the credibility of the regulatory procedures and casts a shadow on those involved in the testing, monitoring and release of transgenic crops. In the interests of transparency and above board conduct, rumors of this kind should be firmly rebutted by the company.

Dr. Suman Sahai , Convenor ofthe Gene Campaign said this cloak and dagger approach to GM crops and Ag –biotechis disgusting and demonstrates more than anything else the immaturity and lack of confidence of the scientific administration . Judging by the stealth and secrecy, it seems that the members of the GEAC and the Department of Biotechnology have a lot to hide. Indeed ifproof were needed that the decisions on Bt cotton andnow GM mustard are detrimental toIndian interests,and that the data cannot withstand public scrutiny, the GEAC provides it in ample measure with its ridiculous, almost criminal obduracy in not making the data public.

About Me

Dr. Suman Sahai, who has had a distinguished scientific career in the field of genetics, is a recipient of the Padma Shri,the Borlaug Award, Outstanding Woman Achiever awards, the BirbalSahni Gold Medal and the Order of the Golden Ark .
Dr. Sahai is founder Chairperson of the Gene Campaign which is a leading research and advocacy organization, working on issues relating to food, nutrition and livelihoods. She has published extensively on science and policy issues and is a member of several national policy forums on scientific research and education, biodiversity and environment, biotechnology and bioethics as well as intellectual property rights.
Dr Sahai chaired India’s Planning Commission Task Force on ‘Agro biodiversity and Genetically Engineered Organisms’, for the XIth Plan. She was a member of the Steering Committee of the National Biodiversity Board , the Expert Committee on Biotechnology Policy and the Bioethics Committee of the Indian Council of Medical Research.She has served on the Research Advisory Committees of national scientific institutions.
Dr Sahai can be reached at www.genecampaign.org and mail@genecampaign.org